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510(k) K210633

Amylase2 by Abbott Ireland Diagnostics Division — Product Code JFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2022
Date Received
March 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catalytic Methods, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

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  • K203771 — Urea Nitrogen2 (May 31, 2022)
  • K210452 — Creatinine2 (March 22, 2022)
  • K203530 — Albumin BCP2 (March 18, 2022)
  • K203248 — Albumin BCG2 (November 23, 2021)

Other clearances for product code JFJ

  • K191454 — Atellica CH Amylase_2 (AMY_2) (July 30, 2019)
  • K182474 — alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIR (May 2, 2019)
  • K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (August 9, 2013)
  • K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINIC (October 3, 2012)
  • K091846 — SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 (October 16, 2009)
  • K080823 — EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT (November 17, 2008)
  • K070064 — AMYLASE EPS REAGENT (May 22, 2007)
  • K062180 — ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM (October 2, 2006)
  • K051447 — SENTINEL PANCREATIC AMYLASE (January 26, 2006)
  • K040920 — AMYLASE LIQUID REAGENT, MODEL A532-200 (May 10, 2004)